- PDF Version (194K) - Print Friendly - Help

Implementation of the ACVM Act: Regulatory changes

1 Introduction

1.1 Reform of the ACVM Act’s administration

The New Zealand Food Safety Authority (NZFSA) has begun a reform of the administration of the Agricultural Compounds and Veterinary Medicines Act 1997 (the ACVM Act). One of the main reasons for the reform is that some regulatory arrangements need to be updated to reflect amendments that were made to the ACVM Act in 2007. The reform is also an opportunity to reconsider the way that the ACVM Act is implemented and to seek feedback from stakeholders. This discussion document is the first in a series that will be released for public consultation as part of the reform process.

The ACVM Act controls agricultural compounds and veterinary medicines used in association with animals and plants. The ACVM Act’s purpose is to:

• prevent or manage risks to public health, trade in primary produce, animal welfare, and agricultural security associated with the use of agricultural compounds

• ensure that the use of agricultural compounds does not result in breaches of domestic food residue standards, and

• ensure the provision of sufficient consumer information about agricultural compounds.

1.2 Purpose of this document

The document focuses on the areas of manufacturing, labelling, advertising and promotion, and own use. “Own use” refers to the practice of using substances (or products) on one’s own animals or plants in a manner that has not been specifically authorised. It is distinct from “off-label” use, which is the use of a product that is available as an agricultural compound in an unauthorised way.

Most of the proposed changes in this document are to do with putting existing regulatory obligations that are currently to be found in a number of places into regulations under the ACVM Act. NZFSA is also revising its standards and information requirements at the same time. All regulations will be subject to consultation during the regulation making process. Where necessary, technical detail will be documented in notices issued after appropriate consultation.

1.3 Background

Manufacturing, labelling, advertising and promotion, and own use are managed in a variety of ways. Conditions of registration are placed on each registered trade name product and also linked to NZFSA standards. Where products are exempt from registration, the conditions are prescribed in regulations. Requirements have also been documented in standards, guidelines and information requirements.

The existing arrangements have been adequate for managing registered trade name products. The regime is not sufficiently flexible to manage the risks that arise around own use. In addition, the relevant exemption from registration does not clearly refer to the ACVM Standard for Own Use of Agricultural Compounds – see Schedule 1 of the Agricultural Compounds and Veterinary Medicines Regulations 2001 (the ACVM Regulations). As a result, regulated parties have not always been aware of the regulatory requirements -- increasing the risk that they inadvertently cause negative effects (such as jeopardising animal welfare). Furthermore, in NZFSA’s view, the regulations to do with manufacturing, labelling and advertising of products that are exempt from registration do not go far enough in terms of setting appropriate regulatory expectations.

The amendment of the ACVM Act in 2007 has provided a wider range of mechanisms for the regulatory control of agricultural compounds and veterinary medicines. The use of these mechanisms is also more transparent now than would have been the case. The changes include the power to:

• make regulations governing a wider range of activities than the ACVM Act previously covered

• issue notices that set specifications and other detailed requirements

• recognise persons (including a manufacturing entity) to carry out specified functions for the purposes of the ACVM Act, and

• approve operating plans.

1.4 Next steps in the reform process

NZFSA will consider and analyse the feedback received on this document. The outcome of this stage of the consultation will provide the basis for making regulations and notices. A specific area of the NZFSA website has been set aside to provide up to date information throughout the reform process (see http://www.nzfsa.govt.nz/acvm/topics/acvm-act/).

NZFSA is also working with other government departments on aspects of the reform, including the scope of the ACVM Act and the risk thresholds and criteria for regulatory intervention. There will be ongoing discussions on the ACVM Act’s relationships with other pieces of legislation, and the most suitable approaches to interdepartmental cooperation and communication.

NZFSA is also working with other government departments on aspects of the reform, including the scope of the ACVM Act and the risk thresholds and criteria for regulatory intervention. There will be ongoing discussions on the ACVM Act’s relationships with other pieces of legislation, and the most suitable approaches to interdepartmental cooperation and communication.